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临床试验/NCT07142603
NCT07142603招募中不适用

Comparative Meal Response to Plant vs. Animal Protein in Women With PCOS

University of Arkansas, Fayetteville2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月18日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Energy expenditure

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is a common endocrine disorder characterized by insulin resistance, hyperandrogenism, and reproductive dysfunction. Dietary strategies that improve postprandial insulin and glucose responses are central to managing metabolic symptoms in PCOS.

Meals higher in protein can attenuate postprandial glycemia and enhance satiety, but the effects may vary by protein source. Animal sources of protein typically have higher essential amino acid content and insulinogenic potential, whereas plant proteins offer fiber and phytochemicals that may influence glycemic dynamics differently. Few studies have directly compared the acute metabolic effects of plant versus animal protein in women with PCOS. Given the distinct pathophysiology of PCOS, extrapolating findings from healthy populations may be misleading.

Understanding protein-specific effects on postprandial insulin, glucose, and appetite-regulating hormones in this group is essential for targeted nutrition guidance. Additionally, plant-based diets are increasingly promoted for cardiometabolic health, but their acute effects in insulin-resistant women remain underexplored. This study will assess whether plant and animal protein meals elicit differential postprandial responses in women with PCOS. Findings may inform dietary recommendations aimed at improving metabolic outcomes in this high-risk population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Females ages 18-50 years
  • Confirmed diagnosis of PCOS
  • Body mass index (BMI) between 18.5 and 35 kg/m2
  • Stable body weight for at least 3 months (+ 5 pounds)
  • Willingness to consume both plant- and animal-based protein meals

排除标准

  • Smoking or use of nicotine products
  • Smoking or use of marijuana products
  • Food allergies or dietary restrictions incompatible with test meals
  • Diagnosed diabetes (type 1 or 2)
  • Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.)

结局指标

主要结局

Energy expenditure

时间窗: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).

Energy expenditure will be measured using indirect calorimetry.

次要结局

  • Appetite(Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).)
  • Plasma amino acid response(Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).)
  • Plasma biomarkers related to appetite(Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).)
  • Appetite(Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).)
  • Plasma amino acid response(Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).)
  • Plasma biomarkers related to appetite(Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie Baum

Associate Professor

University of Arkansas, Fayetteville

研究点 (2)

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